The US Food and Drug Administration (FDA) this week unveiled a Form 483 from April for ADMA Biologics, a company that previously received a complete response letter related to manufacturing ...
The FDA slammed three Indian drugmakers with Form 483s following recent inspections that uncovered unsanitary conditions, broken equipment and poor recordkeeping. Mumbai-based Alkem Labs was cited ...
With observations ranging from dirty packing rooms to incomplete lab control records, Spectrum Laboratory Products’ new FDA manufacturing write-up reads like a guide on what not to do when producing ...
The relationship between regulated life science companies and their public investors is often contentious. Companies need investor money to finance company operations, such as clinical trials, but ...
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